FDA Suggests Less Lead in Baby Food

The U.S. Food and Drug Administration (FDA) issued guidance for baby food manufacturers, and the messages serve as good examples of reports and persuasion:

  • Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry. This is a text report that students could analyze for organization, writing style, evidence, data visualization (or lack there of), etc.

  • Federal Register Notice. This legal-sounding document explains how to submit comments, either by “electronic submission” or “written/paper submission,” an archaic-sounding process. People also can order paper copies of the draft guidance, something you might do in 1970: “Send two self-addressed adhesive labels to assist that office in processing your request.”

Several times, on the website and within in each document, the agency reminds us, “Contains Nonbinding Recommendations Draft-Not for Implementation.” The agency further describes the “guidance”:

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

The approach attempts to involve industry and consumer groups, who likely have a lot to say about the FDA’s data and recommendations. In the introductory website text, the agency says it considers the goals “achievable by industry when control measures are taken to minimize the presence of lead.” We’ll see whether others agree. Already, one consumer group weighed in, saying the guidance “doesn’t go far enough,” while Gerber and other companies are “reviewing” the proposal.